Legal provisions of COM(2018)317 - Amendment of Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products

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dossier COM(2018)317 - Amendment of Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products.
document COM(2018)317 EN
date May 20, 2019

Contents

Article 1 - Amendment of Regulation (EC) No 469/2009

Regulation (EC) No 469/2009 is amended as follows:

(1)in Article 1, the following point is added:

‘(f)“maker” means the person, established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export to third countries or for the purpose of storing, is carried out;’;

(2)Article 5 is replaced by the following:

‘Article 5

Effects of the certificate

1. Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.

2. By way of derogation from paragraph 1, the certificate referred to in paragraph 1 shall not confer protection against certain acts which would otherwise require the consent of the holder of the certificate (“the certificate holder”), if the following conditions are met:

(a)the acts comprise:

(i)the making of a product, or a medicinal product containing that product, for the purpose of export to third countries; or

(ii)any related act that is strictly necessary for the making, in the Union, referred to in point (i), or for the actual export; or

(iii)the making, no earlier than six months before the expiry of the certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate; or

(iv)any related act that is strictly necessary for the making, in the Union, referred to in point (iii), or for the actual storing, provided that such related act is carried out no earlier than six months before the expiry of the certificate.

(b)the maker, through appropriate and documented means, notifies the authority referred to in Article 9(1) in the Member State in which that making is to take place, and informs the certificate holder, of the information listed in paragraph 5 of this Article no later than three months before the start date of the making in that Member State, or no later than three months before the first related act, prior to that making, that would otherwise be prohibited by the protection conferred by a certificate, whichever is the earlier;

(c)if the information listed in paragraph 5 of this Article changes, the maker notifies the authority referred to in Article 9(1) and informs the certificate holder, before those changes take effect;

(d)in the case of products, or medicinal products containing those products, made for the purpose of export to third countries, the maker ensures that a logo, in the form set out in Annex -I, is affixed to the outer packaging of the product, or the medicinal product containing that product, referred to in point (a)(i) of this paragraph, and, where feasible, to its immediate packaging;

(e)the maker complies with paragraph 9 of this Article and, if applicable, with Article 12(2).

3. The exception referred to in paragraph 2 shall not apply to any act or activity carried out for the import of products, or medicinal products containing those products, into the Union merely for the purpose of repackaging, re-exporting or storing.

4. The information provided to the certificate holder for the purposes of points (b) and (c) of paragraph 2 shall be used exclusively for the purposes of verifying whether the requirements of this Regulation have been met and, where applicable, initiating legal proceedings for non-compliance.

5. The information to be provided by the maker for the purposes of point (b) of paragraph 2 shall be as follows:

(a)the name and address of the maker;

(b)an indication of whether the making is for the purpose of export, for the purpose of storing, or for the purpose of both export and storing;

(c)the Member State in which the making and, if applicable, also the storing is to take place, and the Member State in which the first related act, if any, prior to that making is to take place;

(d)the number of the certificate granted in the Member State of making, and the number of the certificate granted in the Member State of the first related act, if any, prior to that making; and

(e)for medicinal products to be exported to third countries, the reference number of the marketing authorisation, or the equivalent of such authorisation, in each third country of export, as soon as it is publicly available.

6. For the purposes of notification to the authority under points (b) and (c) of paragraph 2, the maker shall use the standard form for notification contained in Annex -Ia.

7. Failure to comply with the requirements of point (e) of paragraph 5 with regard to a third country shall only affect exports to that country, and those exports shall, therefore, not benefit from the exception.

8. The maker shall ensure that medicinal products made pursuant to point (a)(i) of paragraph 2 do not bear an active unique identifier within the meaning of Commission Delegated Regulation (EU) 2016/161 (*1).

9. The maker shall ensure, through appropriate and documented means, that any person in a contractual relationship with the maker who performs acts falling under point (a) of paragraph 2 is fully informed and aware of the following:

(a)that those acts are subject to paragraph 2;

(b)that the placing on the market, import or re-import of the product, or the medicinal product containing that product, referred to in point (a)(i) of paragraph 2 or the placing on the market of the product, or the medicinal product containing that product, referred to in point (a)(iii) of paragraph 2 could infringe the certificate referred to in paragraph 2 where, and for as long as, that certificate applies.

10. Paragraph 2 shall apply to certificates that are applied for on or after 1 July 2019.

Paragraph 2 shall also apply to certificates that have been applied for before 1 July 2019 and that take effect on or after that date. Paragraph 2 shall only apply to such certificates from 2 July 2022.

Paragraph 2 shall not apply to certificates that take effect before 1 July 2019.

(*1)  Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).’;"

(3)in Article 11, the following paragraph is added:

‘4.   The authority referred to in Article 9(1) shall publish, as soon as possible, the information listed in Article 5(5), together with the date of notification of that information. It shall also publish, as soon as possible, any changes to the information notified in accordance with point (c) of Article 5(2).’;

(4)Article 12 is replaced by the following:

‘Article 12

Fees

1. Member States may require that the certificate be subject to the payment of annual fees.

2. Member States may require that the notifications referred to in points (b) and (c) of Article 5(2) be subject to the payment of a fee.’;

(5)the following Article is inserted:

‘Article 21a

Evaluation

No later than five years after the date referred to in Article 5(10), and every five years thereafter, the Commission shall carry out an evaluation of Article 5(2) to (9) and Article 11 in order to assess whether the objectives of those provisions have been achieved, and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. In addition to evaluating the impact of the exception of making for the purpose of export, special account shall be taken of the effects of making for the purpose of storing in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate on access to medicines and on public health expenditure, and of whether the waiver and in particular the period provided for in point (a)(iii) of Article 5(2) is sufficient to achieve the objectives referred to in Article 5, including public health.’;

(6)Annexes -I and -Ia as set out in the Annex to this Regulation are inserted.

Article 2 - Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.